Actively Recruiting
Neoadjuvant Therapy With Nab-paclitaxel and Cisplatin for Locally Advanced Esophageal Squamous Cell Carcinoma
Led by Hebei Medical University Fourth Hospital · Updated on 2023-10-10
202
Participants Needed
1
Research Sites
400 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To verify the role of nab-paclitaxel in neoadjuvant therapy for esophageal squamous cell carcinoma, the investigators designed a prospective, randomized, controlled , multicente phase II trial, to investigate the efficacy and safety of nab-paclitaxel combined with cisplatin as neoadjuvant therapy followed by surgery versus surgery alone for esophageal squamous cell carcinoma.
CONDITIONS
Official Title
Neoadjuvant Therapy With Nab-paclitaxel and Cisplatin for Locally Advanced Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age ranges from 18 to 75 years
- Diagnosed with resectable, locally advanced middle-lower esophageal squamous cell carcinoma without distant metastasis (cT1N1M0 or T2-3N0-1M0)
- Enhanced CT confirms potentially resectable lesions without mediastinal infiltration or airway invasion
- No prior systemic antitumor therapy for esophageal squamous cell carcinoma
- ECOG performance status of 0 or 1
- Expected survival longer than 6 months
- Adequate organ function confirmed by lab tests including bone marrow, liver, renal, and coagulation function
- Female patients of child-bearing age agree to use contraception during study and 6 months after; negative pregnancy test before enrollment; non-lactating
- Male patients agree to use contraception during study and 6 months after
- No uncontrolled benign diseases such as infections in kidney, lung, or liver
- Not participating in other clinical trials within 4 weeks before treatment
- Good compliance and understanding of study with signed informed consent form
You will not qualify if you...
- Histologically confirmed esophageal adenocarcinoma
- Presence of distant metastasis or stage IV disease without radical resection
- Prior treatment with other drugs including traditional Chinese medicine before recruitment or non-compliance with study protocol
- Grade 2 or higher peripheral neuropathy or hemorrhage
- Severe cardiovascular diseases including uncontrolled hypertension, unstable angina, recent myocardial infarction, congestive heart failure NYHA > II, severe arrhythmia, or pericardial effusion
- Severe ADH secretion syndrome or poorly controlled diabetes requiring high insulin doses or with HbA1c above 9.0
- Long-term use of anticoagulants or vitamin K antagonists for over 6 months (except low-dose warfarin or aspirin for prevention)
- Major surgery within 4 weeks prior to enrollment or unhealed surgical wounds
- Previous surgeries preventing stomach use for esophageal reconstruction
- Severe infections within 1 week before starting study requiring intravenous antibiotics or antivirals
- Allergies or intolerance to study drugs or excipients
- Other malignant tumors in past 5 years except melanoma skin cancer or cervical carcinoma in situ
- Any contraindications to chemotherapy or surgery
- Pregnant or lactating women
- Medical, social, or psychological conditions preventing study completion or lack of informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Jun Feng Liu
Shijiazhuang, Hebei, China, 050011
Actively Recruiting
Research Team
J
Junfeng Liu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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